1. Field of the Invention
The invention relates to a laryngeal mask that includes at least one airway tube and a mask portion, the mask portion including a top face and a bottom face, the bottom face including a lumen that communicates with the tube interior, and the top face including a closed transition face; and wherein the mask portion is delimited in its periphery by an inflatable cuff at least on the bottom face. The invention also relates to a method of manufacturing such a laryngeal mask.
2. The Prior Art
EP-1 259 595 discloses the manufacture of laryngeal masks by means of rotational moulding, and wherein exclusively the mask portion as such is manufactured in that process.
From EP-9 35 971 and EP 922 465 it is known to manufacture the mask portion by blow moulding.
Laryngeal masks are used in connection with the establishment of passage of air to the respiratory tracts, while simultaneously the air passage to the oesophagus is blocked. The laryngeal mask is shaped such that its lumen within the mask portion as such faces towards the laryngeal opening, and wherein there is provided an inflatable elliptical cuff around that lumen that forms a seal around the laryngeal opening. To the cuff there is a tubular connection that is connected to a balloon part and a valve, and by which the peripheral cuff of the mask is inflated thereby ensuring a tight abutment of the product; likewise it is possible to perform a deflation of the peripheral cuff by extraction of air via said valve.
However, the prior art laryngeal masks are all manufactured as multi-component products, air tube and mask portion not being manufactured integrally but rather as two separate components that are subsequently to be assembled. Likewise it is known that the mask portion as such is manufactured as two components; viz as a cuff portion and a connecting element (mount member) that are subsequently to be connected to each other. On the one hand, such additional assembly process is costly and, on the other, there is also a risk that the laryngeal mask separates at the assembly part as such, which may have serious consequences to the patient in connection with anaesthesia, etc.
It is thus the object of the present invention to provide, on the one hand, a laryngeal mask and a method that remedy the above-referenced problems and whereby it is possible to provide a product that is configured in one piece with respect to mask portion and at least a part of the airway tube portion, thereby eliminating the risk of the two parts separating in use, and wherein the material thickness of the laryngeal mask varies and can be regulated unequivocally by the process. Hereby the requisite mechanical and elastic properties are imparted to the laryngeal mask in selected and well-defined areas.